An observational study in Full Thickness Rotator Cuff Tear, sponsored by University of Michigan. Completed. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-18.
Sponsored by University of Michigan · Observational
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical trials reflect real world settings and thus have greater external generalizability than efficacy trials. The evaluation component in this trial will be three-fold: first, the study team will compare the success of patients undergoing operative versus non-operative management and identify which variables predict success in each group; second, investigators will attempt to predict which patients end up choosing, along with their care giver(s), operative versus non-operative management by examining the predictive capability of a selection of variables; third, investigators will evaluate the clinical research site(s), personnel, and implementation processes for their capability to implement clinical trials with the intent of planning for a future large multi-site clinical trial building on the results of the present study.
University of Michigan is the lead sponsor of 1,503 studies on the registry; 189 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 132 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients presenting to an orthopaedic clinic with full-thickness rotator cuff tears as determined by surgeon opinion and imaging
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients whom elected non-operative treatment
Patients whom elected operative treatment
Procedure: Operative management
Rotator cuff surgery
Veterans Rand VR-12 Quality of Life Score
Time frame: baseline
Veterans Rand VR-12 Quality of Life Score
Time frame: 4 weeks
Veterans Rand VR-12 Quality of Life Score
Time frame: 8 weeks
Veterans Rand VR-12 Quality of Life Score
Time frame: 16 weeks
Veterans Rand VR-12 Quality of Life Score
Time frame: 32 weeks
Veterans Rand VR-12 Quality of Life Score
Time frame: 48 weeks
Veterans Rand VR-12 Quality of Life Score
Time frame: 64 weeks
No study locations are listed for this record.
Plan to share: No — No individual patient data will be shared
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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